1.

Notifying Member: Republic of Korea

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible: Ministry of Food and Drug Safety

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

International Cooperation Office

Ministry of Food and Drug Safety

187 Osongsaengmyeong2-ro, Osong-eup

Heungdoek-gu Cheongju-si

Chungcheogbuk-do, 363-700

Republic of Korea

Tel: (+82) 43 719 1564

Fax: (+82) 43 719 1550

3.

Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Quasi-drugs

5.

Title, number of pages and language(s) of the notified document: Proposed "Regulation on Quasi-Drug Re-Evaluation Procedures" (8 pages, in Korean)

6.

Description of content: With regard to the re-evaluation of quasi-drugs, this proposed regulation establishes the procedures for the selection of products subject to re-evaluation, application process, scope of data submission, pre-notification of the re-evaluation results and follow-up measures, submission of objections, and notification of final results.

7.

Objective and rationale, including the nature of urgent problems where applicable: Maintain safety and efficacy of previously approved and notified quasi-drugs and enforce quasi-drug safety management

8.

Relevant documents: MFDS Notification No. 2015-353 (9 November 2015)

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Final date for comments: 60 days from notification

11.

Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:

Technical Barriers to Trade(TBT) Division

Korean Agency for Technology and Standards (KATS)

93, Isu-ro, Maengdong-myeon, Eumseong-gun

Chungcheongbuk-do

Republic of Korea 369-811

Tel: (+82) 43 870 5525

Fax: (+82 43 870 5682

E-mail: tbt@kats.go.kr

Website : http://www.knowtbt.kr

https://members.wto.org/crnattachments/2015/TBT/KOR/15_4565_00_x.pdf